THERASPHERE NI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-11-29 for THERASPHERE NI manufactured by Mds Nordion.

Event Text Entries

[413423] In a study under hde protocol of therasphere for treatment of unresectable hcc, a pt experiened fever of 39. 8 with chills. The event was judged by clinical site as possibly related to the treatment.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8022247-2005-00015
• MDR Report Key: 649406
• Report Source: 05,06
• Date Received: 2005-11-29
• Date of Report: 2005-11-02
• Date of Event: 2005-05-11
• Date Mfgr Received: 2005-11-02
• Date Added to Maude: 2005-12-07
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: ANN WARBICK-CERONE
• Manufacturer Street: 447 MARCH RD
• Manufacturer City: OTTAWA, ON K2K 1X8
• Manufacturer Country: CA
• Manufacturer Postal: K2K 1X8
• Manufacturer Phone: 5923400
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: THERASPHERE
• Generic Name: RADIOACTIVE MICROSPHERES
• Product Code: IWA
• Date Received: 2005-11-29
• Model Number: NI
• Catalog Number: NI
• Lot Number: NI
• ID Number: NI
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 638897
• Manufacturer: MDS NORDION
• Manufacturer Address: 447 MARCH RD. OTTAWA, ONTARIO CA K2K 1X8

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2005-11-29